hip artrosis hip wear
Conditions
Interventions
Two different hip prostheses with CE mark with known mid to long term follow up
clinical will be used. All patients will receive a total hip prosthesis because
of their invalidity and health problem
Sponsors
Zimmer Biomet Nederland BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: These are standard indications for usage of the Taperloc Complete and Taperloc Microplasty stem. ;Subjects with one of the following indications: Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis. Correction of functional deformity. ;Additional inclusion criteria include: Male or female > 18 and * 70 years of age Subjects willing to return for follow-up evaluations. Subjects able to read and understand Dutch language.
Exclusion criteria
Exclusion criteria: Active Infection (or within 6 weeks after infection) Sepsis Osteomyelitis;Uncooperative patient or patient with neurologic disorders who are incapable of following directions diagnosed Osteoporosis or Osteomalacia Metabolic disorders which may impair bone formation Distant foci of infections which may spread to the implant site Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram Vascular insufficiency, muscular atrophy or neuromuscular disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study endpoint is migration at two year measured with RSA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints are malalignment, incorrect sizing, subsidence and intraoperative fractures, early survival of the hip prosthesis at 2 year and Clinical performance based on the clinician based outcome (HHS and radiological evaluation) and the patient based outcomes (HOOS, EQ5D, Oxford Hip score, Forgotten Hip). One site will perform migration analysis with RSA. Migration at two year will be the primary endpoint for this sub-group. | — |
Countries
Netherlands
Outcome results
None listed